BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE WITH NEEDLE

    MDR report key: 16981271 · Received May 22, 2023

    Report

    Report Number
    3003916417-2023-00110
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 17, 2023
    Report Date
    July 31, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, PACKAGED SOLOMED SYRINGE IS DISPLAYED, NO DEFECTS OR ISSUES ARE OBSERVED. UNABLE TO CONFIRM FAILURE BASED ON IMAGES RECEIVED. PHYSICAL SAMPLES ARE NECESSARY TO FURTHER ANALYZE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1357563, 1132498, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SOLOMED¿ SYRINGE WITH NEEDLE WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE SYRINGE WAS DIFFICULT TO ASPIRATE, TO ASPIRATE THE DRUG LIQUID. CUSTOMER CALLED TO REPORT THAT THE SYRINGE WAS HAVING DIFFICULTY IN ASPIRATION AND APPLICATION. TO ASPIRATE THE LIQUID FROM THE ALGINAC 5000 MEDICATION, I DID NOT ASPIRATE. AFTER TESTING 2 SYRINGES FROM BATCH 1357563 AND 1 SYRINGE FROM BATCH 1132498.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SOLOMED¿ SYRINGE WITH NEEDLE WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE SYRINGE WAS DIFFICULT TO ASPIRATE, TO ASPIRATE THE DRUG LIQUID. CUSTOMER CALLED TO REPORT THAT THE SYRINGE WAS HAVING DIFFICULTY IN ASPIRATION AND APPLICATION. TO ASPIRATE THE LIQUID FROM THE ALGINAC 5000 MEDICATION, I DID NOT ASPIRATE. AFTER TESTING 2 SYRINGES FROM BATCH 1357563 AND 1 SYRINGE FROM BATCH 1132498.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849086 BD SOLOMED¿ SYRINGE WITH NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown